Particle Engineering by Nano Spray Drying: Optimization of Process Parameters with Hydroethanolic versus Aqueous Solutions.

Nano spray drying has emerged as an outstanding platform for engineering micro- and nanoparticles, with growing applications in various areas of drug delivery. As a new technology involving distinct technical design, parameters of the nano spray drying process are not fully elucidated. In a quality-by-design approach, the aim of the current study was to gain thorough understanding of critical determinants of product characteristics in the Büchi Nano Spray Dryer B-90. Following a factorial experimental design, a series of spray drying experiments were conducted to gain new insights into the influences of the inlet temperature, the spray solvent, and the solute concentration in the spray solution on the yield, the moisture content, and the particle size of the nano spray-dried powder material. Special consideration was given to the potential of using hydroethanolic in comparison with aqueous solvent systems and to particle engineering for pulmonary drug delivery. Lactose and mannitol, widely used as excipients in dry powder inhalation formulations, were used as model materials. Lactose and mannitol are known to spray dry in amorphous and crystalline forms, respectively. The yields of spray drying of lactose and mannitol amounted generally to 71.1 ± 6.6% w/w and 66.1 ± 3.5% w/w, respectively. The spray-dried materials exhibited generally a number-weighted median particle diameter of 1.6 ± 0.2 µm and a volume-weighted median particle diameter of 5.1 ± 1.0 µm. A detailed analysis of the results improved understanding of the interplay between process parameters in the Nano Spray Dryer. The results demonstrate that optimization of spray generation is the key to yield optimization. On the other hand, particle size is determined by the spray mesh pore size and the spray solution degree of saturation. Selection of an appropriate spray solvent and using spray solution additives could optimize spray flow. In parallel, the spray solvent and the solute concentration in the spray solution determine the degree of saturation. Guidance on optimization of particle engineering by nano spray drying is provided.

Nano Spray-Dried Drugs for Oral Administration: A Review.

Spray drying is an important technology that is fast, simple, reproducible, and scalable. It has a wide application range, that is, in food, chemicals, and encapsulation of pharmaceuticals. The technology can be divided into conventional spray drying and nano spray drying. The key advantage of nano spray drying is the production of drug-loaded nanosized particles for various drug delivery applications. The recent developments in nano spray dryer technology and the market launch of the Nano Spray Dryer B-90 by Büchi Labortechnik AG in 2009 enabled the production of submicron spray-dried particles. This review focuses on nanosized drug delivery systems intended for oral administration produced by nano spray drying. First, the nano spray drying concept, the basic technologies implemented in the equipment, and the effects of the various process parameters on the final dry submicron powder properties are presented. Then, the topics of new formulation strategies of oral drugs are highlighted with examples that have entered the research literature in recent years. Next, the subjects of direct conversion of poorly water-soluble drugs, encapsulation of drugs, and drying of preformed nanoparticles are considered. Finally, topics such as morphology, particle size, size distribution, surface analysis, bioavailability, drug release, release kinetics, and solid-state characterization (by differential scanning calorimetry, X-ray diffraction, Fourier transform infrared spectroscopy, nuclear magnetic resonance) of oral drug delivery systems produced by nano spray drying are discussed. The review attempts to provide a comprehensive knowledge base with current literature and foresight to researchers working in the field of pharmaceutical technology and nanotechnology and especially in the field of nano spray drying.

Nano spray drying for encapsulation of pharmaceuticals.

Many pharmaceuticals such as pills, capsules, or tablets are prepared in a dried and powdered form. In this field, spray drying plays a critical role to convert liquid pharmaceutical formulations into powders. In addition, in many cases it is necessary to encapsulate bioactive drugs into wall materials to protect them against harsh process and environmental conditions, as well as to deliver the drug to the right place and at the correct time within the body. Thus, spray drying is a common process used for encapsulation of pharmaceuticals. In view of the rapid progress of nanoencapsulation techniques in pharmaceutics, nano spray drying is used to improve drug formulation and delivery. The nano spray dryer developed in the recent years provides ultrafine powders at nanoscale and high product yields. In this paper, after explaining the concept of nano spray drying and understanding the key elements of the equipment, the influence of the process parameters on the final powders properties, like particle size, morphology, encapsulation efficiency, drug loading and release, will be discussed. Then, numerous application examples are reviewed for nano spray drying and encapsulation of various drugs in the early stages of product development along with a brief overview of the obtained results and characterization techniques.

Nano and microparticle engineering of water insoluble drugs using a novel spray-drying process.

In the current study nano and microparticle engineering of water insoluble drugs was conducted using a novel piezoelectric spray-drying approach. Cyclosporin A (CyA) and dexamethasone (DEX) were encapsulated in biodegradable poly(D,L-lactide-co-glycolide) (PLGA) grades of different molecular weights. Spray-drying studies carried out with the Nano Spray Dryer B-90 employed with piezoelectric driven actuator. The processing parameters including inlet temperature, spray mesh diameter, sample flow rate, spray rate, applied pressure and sample concentration were examined in order to optimize the particle size and the obtained yield. The process parameters and the solute concentration showed a profound effect on the particle engineering and the obtained product yield. The produced powder presented consistent and reproducible spherical particles with narrow particle size distribution. Cyclosporin was found to be molecularly dispersed while dexamethasone was in crystalline state within the PLGA nanoparticles. Further evaluation revealed excellent drug loading, encapsulation efficiency and production yield. In vitro studies demonstrated sustained release patterns for the active substances. This novel spray-drying process proved to be efficient for nano and microparticle engineering of water insoluble active substances.

Evaluation of the Nano Spray Dryer B-90 for pharmaceutical applications.

The vibrating mesh spray technology implemented in the Nano Spray Dryer B-90 was evaluated for pharmaceutical applications by spray drying common pharmaceutical excipients (e.g. trehalose, mannitol) and model drugs (e.g. griseofulvin). Aerosol droplet size measurements investigated the influence of spray solution factors (e.g. viscosity, surface tension) and of vibrating mesh aperture sizes on particle characteristics. Particle deposition on the spray nozzle was addressed by analyzing the influence of spray solute concentration and solvent on the process outcome. Submicron particles with 0.5 ?m and 0.8 ?m mean particle size were obtained at high yields for 50?mg powder amounts.

Nanoparticles by spray drying using innovative new technology: the Büchi nano spray dryer B-90.

Spray drying technology is widely known and used to transform liquids (solutions, emulsions, suspension, slurries, pastes or even melts) into solid powders. Its main applications are found in the food, chemical and materials industries to enhance ingredient conservation, particle properties, powder handling and storage etc. However, spray drying can also be used for specific applications in the formulation of pharmaceuticals for drug delivery (e.g. particles for pulmonary delivery). Büchi is a reference in the development of spray drying technology, notably for laboratory scale devices. This study presents the Nano Spray Dryer B-90, a revolutionary new sprayer developed by Büchi, use of which can lower the size of the produced dried particles by an order of magnitude attaining submicron sizes. In this paper, results are presented with a panel of five representative polymeric wall materials (arabic gum, whey protein, polyvinyl alcohol, modified starch, and maltodextrin) and the potentials to encapsulate nano-emulsions, or to formulate nano-crystals (e.g. from furosemide) are also shown.

Two-fraction and three-fraction continuous simulated moving bed separation of nucleosides.

A new experimental set-up and a new simulated moving bed (SMB) operation are presented in this work. A desktop SMB unit developed as a modification of the commercial AKTA explorer working platform has been utilized for the separation of different mixtures of nucleosides. Both two fraction and three fraction SMB separations have been carried out, the latter made possible by the adoption of a new SMB configuration and operating mode (three fraction SMB, 3F-SMB, operation). Experiments demonstrate the feasibility of the 3F-SMB operation, and confirm the trends predicted based on considerations about retention of the components to be separated along the unit.